AO Multicenter Intervention Trial for Prevention of Surgical Site Infection (AOPOSSI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03380273|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : January 23, 2019
This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Behavioral: Implementation of the AO Trauma SSI Prevention Bundle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8476 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||During two years, patients with fractures are recorded and the occurence of surgical site infections (SSI) in these patients is monitored in different sites over the world. After two years, a bundle of known prevention measures are teached and enforced in these sites. Then the occurence of SSI in fracture patients is monitored for another two years to see whether the bundle decreased the SSI occurence.|
|Masking:||None (Open Label)|
|Masking Description:||It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.|
|Official Title:||AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
No Intervention: pre-intervention
The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed.
Here the same observations are made as in the first arm, however this is after the hospital staff was thought the prevention measures (all by themselves approved) and enforced to be applied.
Behavioral: Implementation of the AO Trauma SSI Prevention Bundle
AOT SSI Prevention Bundle
- Infection Rate [ Time Frame: within 3 months after surgery ]Surgical site infection rate as defined by CDC or FRI definition
- Implementation success of the AOT SSI Prevention Bundle [ Time Frame: up to 48 months ]Compliance rate for each measure of the bundle before and after the intervention
- Evaluation of attitudes, perception and knowledge concerning SSI [ Time Frame: up to 48 months ]Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle
- Surgeon satisfaction [ Time Frame: up to 48 months ]Cross sectional survey of opinion concerning user friendliness of the AOT SSI Prevention Bundle, value of the educational intervention and intention to adopt the AOT SSI Prevention Bundle long term before and after its implementation
- Health-economic analysis [ Time Frame: up to 48 months ]The clinical effectiveness of the implementation of the AOT SSI Prevention Bundle and consecutively the costs saved by preventing infections and its treatment is compared against the costs which have to be invested in order to implement the AOT SSI Prevention Bundle (e.g. costs generated by development of teaching material, time needed to teach/implement the intervention, extra material needed according to the interventions etc.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380273
|Contact: Claudia Zimmerli, PhDfirstname.lastname@example.org|
|Contact: Severine Hurni, PhDemail@example.com|
|Principal Investigator:||Stephen Kates, MD||VCU Health|